Ancillary reviews

Applies to: all

Ancillary reviews — radiation safety, biosafety, pharmacy, conflict of interest, scientific review, and the like — stay with the relying site even when IRB review is ceded, and they are one of the most common sources of delay in single IRB studies. The HSC's guidance defines ancillary reviews, recommends when to centralize them, how to time them relative to IRB review, and how to allocate responsibility between the Reviewing IRB, the Relying Institution, and the study teams.

• Recommendations for the Harmonization of Ancillary Reviews (package)
• Ancillary review implementation checklist
• SMART Talk on ancillary reviews (March 2021): video · slides

Under the Agreement, local ancillary reviews are a Local Consideration the Relying Institution must identify and communicate — see Local Considerations and Other Considerations.

See also - Local Considerations and Other Considerations - Harmonization guidance by topic